Quality Control Requirement HHV 5014 NUTRACEUTICAL FORMULATION Quality Control Requirement LECTURER: SIR NOOR MOHD SYAHRIN STUDENTS: AFIQ NINA SYAHMI

Definition Quality: The status of a drug that is determined by identity, purity, content, and other chemical, physical, or biological properties, or by the manufacturing processes Quality Control: Is a product oriented and focuses on defect identification

Quality Control of Tablets General Appearance: Size, shape Thickness This is important to facilitate packaging and to decide which tablet compressing machine to use. Organoleptic properties: color odor

BRITISH PHARMACOPOEIA Uncoated tablet: Disintegration test Uniformity of weight Effervescent tablet: Coated tablet:

Gastro resistant tablet: Disintegration test Modified release tablet: Uniformity of weight. Dispersible tablet: Uniformity of dispersion Uniformity of weight

INDIAN PHARMACOPOEIA Uncoated tablet: - Uniformity of container content Content of active ingredient Uniformity of weight Uniformity of content Disintegration test Enteric coated tablet: SINENSITIN

Uniformity of dispersion Disintegration Dispersible tablet: Uniformity of dispersion Disintegration Soluble tablet: Disintegration test Effervescent tablet: Disintegration/ Dissolution / Dispersion test

UNITED STATES PHARMACOPOEIA Physical tests applicable to tablet formulation:- Bulk density /Tapped density of powder Powder fineness Loss on drying Disintegration test Tablet friability Dissolution test Drug release testing Uniformity of dosage form Container permeation test Labelling of inactive ingredients

Official and unofficial tests Weight variation disintegration dissolution drug content Non-Official Tests: Hardness friability

Non official tests Hardness (crushing strength): It is the load required to crush the tablet when placed on its edge. Why do we measure hardness? To determine the need for pressure adjustments on the tableting machine. Hardness can affect the disintegration. So if the tablet is too hard, it may not disintegrate in the required period of time. If the tablet is too soft, it will not withstand the handling during subsequent.

Factors Affecting the Hardness: Compression of the tablet compressive force. Amount of binder. (More binder à more hardness) Method of granulation in preparing the tablet (wet method gives more hardness than direct method, Slugging method gives the best hardness) Limits: 5 kilograms minimum 8 kilograms maximum

Procedure... Make hardness test on 5 tablets Then take the average hardness.

Friability: It is the tendency of tablets to powder, chip, or fragment and this can affect the elegance appearance, consumer acceptance of the tablet, and also add to tablet’s weight variation or content uniformity problems Friability also is a property that is related to the hardness of the tablet. An instrument called friabilator is used to evaluate the ability of the tablet to withstand abrasion in packaging, handling, and shipping.

Quality Control of Capsules BRITISH PHARMACOPOEIA TEST: disintegration of capsules Uniformity of Weight of capsules